Actinic KeratosisPhase 2NCT00700063
A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
A Phase 2 study testing PEP005 Topical Gel in people with Actinic Keratosis, run by Peplin at 28 sites in 2 countries.
Trial summary
This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the face or scalp. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- PEP005 Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 265 participants
- Where
- 28 sitesin 2 countries
- Study dates
- Jun 2008to Oct 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be male or female
- Female patients must be of
- Non-childbearing potential;
- Childbearing potential, provided negative pregnancy test and using effective contraception
- 4 to 8 AK lesions on the face or scalp
Who cannot join
- Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area.
- Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system: within 4 weeks.
- Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy:
- within 8 weeks and 2 cm of treatment area
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States25 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Altman Dermatology Associates
Arlington Heights, Illinois, 60005
DermResearch, Inc. 8140 N. MoPac, Bldg. 3, Suite 120,
Austin, Texas, 78759
Northwest Clinical Trial
Boise, Idaho, 83704
Christie Clinic
Champaign, Illinois, 61820
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Burke Pharmaceutical Research
Hot Springs, Arizona, 71913
Suzanne Bruce and Associates, The Center for Skin Research
Houston, Texas, 77056
Dermatology Research of Arkansas
Little Rock, Arkansas, 72205
Koppel Dermatology
Los Angeles, California, 70072
Dermatology Research Associates
Los Angeles, California, 90045
Dermatology Research Associates
Nashville, Tennessee, 37203
TKL Research, Inc.
Paramus, New Jersey, 07652
Philadelphia Institute of Dermatology
Philadelphia, Pennsylvania, 19034
Oregon Medical Research Center
Portland, Oregon, 97223
Integrated Research Group Inc
Riverside, California, 92506
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Progressive Clinical Research
San Antonio, Texas, 78229
Skin Surgery Medical Group Inc
San Diego, California, 92117
470 Castro St Suite 202-204
San Francisco, California, 94114
South Bend Clinic
South Bend, Indiana, 46617
Spencer Derm and Skin Surgery Center
St. Petersburg, Florida, 33716
Dermatology Associates of Tyler
Tyler, Texas, 75703
Solano Clinical Research
Vallejo, California, 94589
Dermatology Specialists Inc
Vista, California, 92083
Australia3 sites
The Skin Centre
Benowa, Queensland, 4217
Siller Medical
Brisbane, Queensland, 4000
Southderm Pty Ltd
Kogarah, New South Wales, 2217
About this study
Official title: A Multicenter, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the face or scalp.
- Conditions
- Actinic Keratosis
- Being tested
- PEP005 Topical Gel, Vehicle gel
- Keywords
- Peplin, Actinic keratosis, PEP005
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP005 Topical GelDrug
0.005%, two days treatment
PEP005 Topical GelDrug
0.01%, two days treatment
PEP005 Topical GelDrug
0.015%, two days treatment
Vehicle gelDrug
two days treatment
PEP005 Topical GelDrug
0.005%, three days treatment
PEP005 Topical GelDrug
0.01%, three days treatment
PEP005 Topical GelDrug
0.015%, three days treatment
Vehicle gelDrug
three days treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: PEP005 Topical Gel |
| 2 | Experimental | Not described Receives: Drug: PEP005 Topical Gel |
| 3 | Experimental | Not described Receives: Drug: PEP005 Topical Gel |
| 4 | Placebo comparator | Not described Receives: Drug: Vehicle gel |
| 5 | Experimental | Not described Receives: Drug: PEP005 Topical Gel |
| 6 | Experimental | Not described Receives: Drug: PEP005 Topical Gel |
| 7 | Experimental | Not described Receives: Drug: PEP005 Topical Gel |
| 8 | Placebo comparator | Not described Receives: Drug: Vehicle gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs Recorded Throughout the Study
Incidence of AEs recorded throughout the study
Measured: 57 days
Incidence of SAE Recorded Throughout the Study
Incidence of SAE recorded throughout the study
Measured: 57 days
Incidence Rate and Severity of LSRs Following Study Medication Application
The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit.
The actual value and change from baseline in the composite LSR score were also summarized.
Measured: Baseline
Incidence Rate and Severity of LSRs Following Study Medication Application
The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit.
The actual value and change from baseline in the composite LSR score were also summarized.
Measured: Day 57
Incidence of Hyperpigmentation Following Study Medication Application
The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted.
Measured: Baseline
Incidence of Hyperpigmentation Following Study Medication Application
The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)
Measured: Day 57
Incidence of Hypopigmentation Following Study Medication Application
The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)
Measured: Baseline
Incidence of Hypopigmentation Following Study Medication Application
The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)
Measured: Day 57
Incidence of Scarring Following Study Medication Application
The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)
Measured: Baseline
Incidence of Scarring Following Study Medication Application
The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent).
Measured: Day 57
Complete Clearance Rate of AK Lesions;
Defined as the number of patients at the day 57 post-treatment visit with no clinically visible AK lesions in the selected treatment area
Measured: Day 57
Secondary outcomes (1)
Efficacy (Clearance of AK Lesions) Partial Clearance Rate
Partial clearence rate, defined as the number of patients at the Day 57 visit with a 75% or greater reduction in the number of AK lesions identified at baseline, in the Face and Scalp
Measured: 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peplin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700063
- Sponsor's protocol ID
- PEP005-015
- Status last verified
- Mar 2015
- First submitted
- 15 Jun 2008
- Last updated
- 14 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
- ClinicalTrials.gov ID
- NCT00700063
- Acronym / sponsor ID
- PEP005-015
- Conditions
- Actinic Keratosis
- Keywords
- Peplin, Actinic keratosis, PEP005
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- PeplinIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 18 Jun 2008 (estimated)
- Results
- Posted 22 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the face or scalp.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PEP005 Topical Gel |
| 2 | Experimental | Drug: PEP005 Topical Gel |
| 3 | Experimental | Drug: PEP005 Topical Gel |
| 4 | Placebo comparator | Drug: Vehicle gel |
| 5 | Experimental | Drug: PEP005 Topical Gel |
| 6 | Experimental | Drug: PEP005 Topical Gel |
| 7 | Experimental | Drug: PEP005 Topical Gel |
| 8 | Placebo comparator | Drug: Vehicle gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be male or female
- Female patients must be of
- Non-childbearing potential;
- Childbearing potential, provided negative pregnancy test and using effective contraception
- 4 to 8 AK lesions on the face or scalp
Key exclusion criteria (4 listed)
- Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area.
- Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system: within 4 weeks.
- Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy:
- within 8 weeks and 2 cm of treatment area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEP005 Topical Gel0.005%, two days treatment | Drug | 1 |
| PEP005 Topical Gel0.01%, two days treatment | Drug | 2 |
| PEP005 Topical Gel0.015%, two days treatment | Drug | 3 |
| Vehicle geltwo days treatment | Drug | 4 |
| PEP005 Topical Gel0.005%, three days treatment | Drug | 5 |
| PEP005 Topical Gel0.01%, three days treatment | Drug | 6 |
| PEP005 Topical Gel0.015%, three days treatment | Drug | 7 |
| Vehicle gelthree days treatment | Drug | 8 |
Primary outcome
Incidence of AEs Recorded Throughout the Study
Time frame: 57 days
Incidence of AEs recorded throughout the study
Incidence of SAE Recorded Throughout the Study
Time frame: 57 days
Incidence of SAE recorded throughout the study
Incidence Rate and Severity of LSRs Following Study Medication Application
Time frame: Baseline
The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit. The actual value and change from baseline in the composite LSR score were also summarized.
Incidence Rate and Severity of LSRs Following Study Medication Application
Time frame: Day 57
The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit. The actual value and change from baseline in the composite LSR score were also summarized.
Incidence of Hyperpigmentation Following Study Medication Application
Time frame: Baseline
The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted.
Incidence of Hyperpigmentation Following Study Medication Application
Time frame: Day 57
The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)
Incidence of Hypopigmentation Following Study Medication Application
Time frame: Baseline
The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)
Incidence of Hypopigmentation Following Study Medication Application
Time frame: Day 57
The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)
Incidence of Scarring Following Study Medication Application
Time frame: Baseline
The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)
Incidence of Scarring Following Study Medication Application
Time frame: Day 57
The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent).
Complete Clearance Rate of AK Lesions;
Time frame: Day 57
Defined as the number of patients at the day 57 post-treatment visit with no clinically visible AK lesions in the selected treatment area
1 secondary outcome
Efficacy (Clearance of AK Lesions) Partial Clearance Rate
Time frame: 57 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Food and Drug AuthorityLink provided by the sponsor.
- Therapeutic Goods AdministrationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEP005 Topical Gel in people with Actinic Keratosis, run by Peplin at 28 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs Recorded Throughout the Study (time frame: 57 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2015.